Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
153625–153648 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 07, 1984
VARIABLE HEIGHT TRANSFER CHAIR
K841398 · FSA
Setma, Inc.
General Hospital · 34d
Cleared May 07, 1984
AB VACUUM EXTRACTOR SILC-CUP
K841492 · HDB
Medela, Inc.
Obstetrics & Gynecology · 27d
Cleared May 07, 1984
MUELLER-HINTON BROTH
K841560 · JTZ
Gibco Laboratories Life Technologies,...
Microbiology · 20d
Cleared May 07, 1984
HYPODERMIC NEEDLES
K841577 · FMI
Ava Medical Products of Canada, Inc.
General Hospital · 20d
Cleared May 07, 1984
DISPOSABLE SYRINGE
K841578 · FMF
Ava Medical Products of Canada, Inc.
General Hospital · 20d
Cleared May 07, 1984
RHESUS SV5/SV40
K841665 · KIR
Viromed Laboratories, Inc.
Pathology · 14d
Cleared May 07, 1984
RABBIT KIDNEY CELLS
K841666 · KIR
Viromed Laboratories, Inc.
Pathology · 14d
Cleared May 07, 1984
MAC LEE SITZ BATH
K841711 · KTC
Mac Lee Medical Products
Physical Medicine · 13d
Cleared May 07, 1984
COLUMBIA CNA AGAR
K841754 · JSJ
The Montana Deaconess Medical Center
Microbiology · 10d
Cleared May 02, 1984
CYTOMEGALOVIRUS ANTIBODY FLUORO-KIT II
K833089 · GQH
Clinical Sciences, Inc.
Microbiology · 233d
Cleared May 02, 1984
COMFEEL PROTECTIVE FILM
K833567 · EXB
Coloplast A/S
Gastroenterology & Urology · 203d
Cleared May 02, 1984
PERFORATOR BUR
K834093
Treace Medical, Inc.
General & Plastic Surgery · 156d
Cleared May 02, 1984
HSV ANTIGEN ELISA KIT
K834449 · LGC
Ortho Diagnostic Systems, Inc.
Microbiology · 135d
Cleared May 02, 1984
CELLTRAK-B
K834585 · FRZ
R&D Systems, Inc.
Hematology · 125d
Cleared May 02, 1984
RENAPAK CONCENTRATE MIXING SYS.
K840182 · FKQ
Renal Systems, Inc.
Gastroenterology & Urology · 106d
Cleared May 02, 1984
ACTIVE LIFE ONE-PIECE STOMA CAP
K840567 · EXB
Convatec, A Division of E.R. Squibb &...
Gastroenterology & Urology · 84d
Cleared May 02, 1984
ACTIVE LIFE ONE-PIECE CLOSED-END POUCH
K840568 · EXB
Convatec, A Division of E.R. Squibb &...
Gastroenterology & Urology · 84d
Cleared May 02, 1984
DIALYSIS ADMIN. SET - I.V.
K840654 · KOC
Cp Medical
Gastroenterology & Urology · 77d
Cleared May 02, 1984
PACEMAKER 147 VVI-THE OPTINIA
K840701 · DXY
Telectronics, Inc.
Cardiovascular · 75d
Cleared May 02, 1984
ENTEROCYSIS TUBE W/GUIDE WIRE & CONNECT
K840752 · KNT
E-Z-Em, Inc.
Gastroenterology & Urology · 69d
Cleared May 02, 1984
PEDIA-TRAKE CRICOTHYROTOMY KIT
K840925 · BTO
Intl. Medical Devices , Ltd.
Anesthesiology · 61d
Cleared May 02, 1984
FIBRINOGEN ASSAY KIT
K841020 · KQJ
Helena Laboratories
Hematology · 51d
Cleared May 02, 1984
TECHNICON RA-1000 SYS CO2
K841080 · CHS
Technicon Instruments Corp.
Chemistry · 50d
Cleared May 02, 1984
IMMPULSE AMIKACIN ASSAY REAGENTS
K841161 · KLQ
Paragon Diagnostics, Inc.
Toxicology · 44d